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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Recognition 12/23/2016 
FR Recognition Number 13-85
Standard
CLSI AUTO11-A2
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
Scope/Abstract
This document provides a framework for communication of information technology security issues between the in vitro diagnostic system vendor and the health care organization.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§862.2100 Calculator/Data Processing Module, For Clinical Use Class 1 JQP
Automated instrumentation under: Part 862 Clinical Chemistry and Clinical Toxicology Devices Part 864 Hematology and Pathology Devices Part 866 Immunology and Microbiology Devices
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued on January 14, 2005.

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2014.
FDA Technical Contact
 James Mullally
  FDA/OMPT/CDRH/OIR/DCTD/CTXB/
  240-402-5021
  james.mullally@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
Software/Informatics
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